MAUDE Adverse Event Report: MEDTRONIC XOMED, INC. XPS® HANDPIECE - VISAO®; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE

Model Number	3334800T
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The one-minute pre-repair temperature test results at initial inspection are as follows: 26.4c at the rear, 32.8c at the middle, and 61.5c at the nose.The reported issue of overheating was confirmed and the handpiece was noisy while running.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the handpiece overheated.There was no patient injury.
Additional Manufacturer Narrative
The product analysis indicates that the initial inspection of the handpiece confirmed the reported event of overheating.Inside the handpiece, the nose, collar, release collar, ball, o-ring, and bearing were rusty and corroded.The motor cable assembly did not pass electrical testing (protective earth resistance).The handpiece was cleaned.The motor cable assembly, nose, release collar, ball, o-ring, and bearing were replaced.Final checkout was completed.The handpiece was tested to manufacturing specifications.If information is provided in the future, a supplemental report will be issued.

• Brand Name: XPS® HANDPIECE - VISAO®
• Common Device Name: DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
• Manufacturer (Section D): MEDTRONIC XOMED, INC.; 6743 southpoint drive north; jacksonville FL 32216
• MDR Report Key: 6608320
• Report Number: 1045254-2017-00172
• Device Sequence Number: 369433
• Product Code: ERL
• UDI-Device Identifier: 00885074107349
• UDI-Public: 00885074107349
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K041523
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 3334800T
• Device Catalogue Number: 3334800T
• Device Lot Number: 205310895
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2017
• Supplement Date Received by Manufacturer: 05/23/2017
• Initial Report FDA Received Date: 06/02/2017
• Supplement Report FDA Received Date: 08/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1